Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020) (T003EFUP2020)

March 24, 2026 updated by: Istituto Superiore di Sanità

A Roll-Over Observational Study for the Extended Follow-Up of the Volunteers of the ISS T-003 Trial (ISS T-003 EF-UP2020)

A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.

Study Overview

Status

Completed

Conditions

Detailed Description

The volunteers enrolled in the South African ISS T-003 trial (ClinicalTrials.gov NCT01513135; SANCTR: DOH-27-0211-3351) were recently enrolled in an observational study to extend the follow-up of the trial. The results of this study (ISS T-003 EF-UP, ClinicalTrials.gov NCT02712489; SANCTR: DOH-27-0615-4948) indicate the maintenance of anti-Tat Ab in a vast proposition of vaccinees.

The new roll-over observational study (ISS T-003 EF-UP2020; SANCTR: DOH-27-072022-7347) is to be conducted to further extend the follow-up of the participants of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.

To this aim volunteers of the ISS T-003 study are included in a new 6-months study, with visits at weeks 0 and 24, during which the persistence and levels of anti-Tat antibodies (primary endpoint) and the CD4+ T-cell and HIV-1 plasma viraemia levels (secondary endpoint) will be evaluated. In addition, depending on the availability of residual specimens (PBMC, serum and plasma), further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers. Clinical signs and symptoms of disease progression and AIDS-defining events will also be recorded.

Study Type

Observational

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Medunsa, Gauteng, South Africa
        • Mecru Clinical Research Unit (MeCRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Enrolment will be open to all patients who participated to the extended follow-up ("ISS T-003 EF-UP) of the therapeutic phase II trial of the Tat vaccine "ISS T-003".

Potentially all patients enrolled in the ISS T-003 EF-UP study

Description

Inclusion Criteria:

  • previous participation in the ISS T-003 EF-UP study without withdrawal of consent;
  • availability to participate in the ensuing extended follow-up study;
  • signed informed consent.

Exclusion Criteria:

  • The absence of any of the above criteria will exclude the participants from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Enrolled patients exiting the ISS T-003 EF-UP study
No intervention - No intervention is foreseen in this Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Tat humoral Immune responses
Time Frame: Week 0 and week 24
Changes of anti-Tat serum antibody levels
Week 0 and week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4+ T cells levels
Time Frame: Week 0 and week 24
Evaluation of CD4+ T cell counts
Week 0 and week 24
HIV-1 plasma viremia
Time Frame: Week 0 and week 24
Evaluation of HIV-1 RNA plasma levels
Week 0 and week 24
HIV-1 reservoir
Time Frame: Week 0 and week 24
HIV-1 proviral DNA copies in blood
Week 0 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Superiore di Sanità

Investigators

  • Principal Investigator: Maphoshane MN Nchabeleng, MD, Sefako Makgatho Health Sciences University - Mecru Clinical Research Unit (MeCRU),

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS T-003 EF-UP2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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